From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EOI wins FDA nod for FLXfit15 expandable cage EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance […]
Medtech stories we missed this week: Sept. 22, 2017
From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, […]
5 DeviceTalks Boston exhibitors you should know
DeviceTalks Boston is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies. The event is hosted by MassDevice. Those who attend the event can expect to network with other medtech enthusiasts, attend in-depth interviews with leaders in the industry and panel discussions about medical devices and […]
FDA clarifies if microneedling should be classified as a medical device
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have published new guidance clarifying how they determine if microneedling products used for skin treatments qualify as medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
South Korean regulators change new medical device regulations
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Russian regulators changing medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Medtech stories we missed this week: Sept. 15, 2017
From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to […]
FDA plans to launch Premarket Approval pilot program for high-risk medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to launch a new pilot program to develop a more efficient premarket approval (PMA) market pathway for some high-risk medical devices. The opinions expressed in this blog post are the author’s only and do not […]
Medtech stories we missed this week: September 8, 2017
From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating […]
FDA user fees for medical device companies expect 33% rise in 2018
By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrants will increase across the board for the agency’s next fiscal year starting October 1, 2017. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]